China approves adalimumab copy biological HLX03

Biosimilars/News | Posted 08/01/2021 post-comment0 Post your comment

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 7 December 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its adalimumab copy biological HLX03.

Approved V13G05

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

HLX03 has been approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis in China and is the first product from Henlius to be approved for the treatment of autoimmune diseases.

Henlius reported that during the development process of HLX03, the company ‘strictly followed the NMPA’s guidelines’ and has carried out ‘multiple head-to-head comparisons between HLX03 and reference adalimumab’. The company added that ‘results from analytical studies, non-clinical studies and clinical studies showed that HLX03 is highly similar to reference adalimumab in terms of quality, safety and efficacy’.

HLX03 is the third monoclonal antibody (mAb) developed by Henlius to be approved in China. The company has also gained NMPA approval for its rituximab biosimilar Hanlikon (HLX01), the first China-developed copy biological following the new guidelines [1, 2], and for its trastuzumab biosimilar HLX02.

HLX02, which has the brand name Zercepac in Europe, was approved in Europe in July 2020, making it the first China-developed mAb biosimilar to be approved in the region [3].

Wanbang Biopharma, which is a subsidiary of Fosun Pharma and has been in the field of rheumatology for many years, will be responsible for the commercialization of HLX03 in China.

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1. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. Chinese guidelines for copy biologicals []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from: 
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Zercepac []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 8]. Available from:

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Source: Henlius

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